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CompletedNCT00971061Updated Sep 4, 2009

Ahmed Glaucoma Valve and Single-Plate Molteno Implants in Treatment of Refractory Glaucoma

A Phase 3 interventional study of Ahmed valve implant and Molteno single-plate implant (MSPI) in Refractory Glaucoma, sponsored by Vanak Eye Surgery Center. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2009-09-04.

Sponsored by Vanak Eye Surgery Center · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

The purpose of this study is to investigate the efficacy and safety of the Ahmed valve implant (AVI) and the Molteno single-plate implant (MSPI) in eyes with refractory glaucoma during a follow-up period of 24 months.

02

Conditions studied

  • Refractory Glaucoma

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Keywords

  • Ahmed valve
  • single-plate Molteno implant
  • refractory glaucoma
  • surgical treatment
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 72 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Vanak Eye Surgery Center is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • refractory glaucoma, defined as uncontrolled IOP despite maximal anti-glaucoma medication, previously failed nonseton surgical treatment, or a combination thereof.

Exclusion criteria

Exclusion Criteria:

  • age less than 40 years
  • a visual acuity of no light perception
  • lens opacity
  • elevated IOP associated with silicone oil previous glaucoma drainage device implantation in the same eye
  • previous cyclodestructive treatment
  • increased risk of endophthalmitis posterior segment disorders
  • pre-existing ocular comorbidities.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    MSPI

    Molteno single-plate implant

    Device: Molteno single-plate implant (MSPI)

  • Active comparator
    AVI

    Ahmed valve implant

    Device: Ahmed valve implant

Interventions

  • DeviceAhmed valve implant

    184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)

  • DeviceMolteno single-plate implant (MSPI)

    134 mm2 surface area single-plate Molteno implant (Molteno Ophthalmic Limited, Dunedin, New Zealand)

06

What researchers measure

Primary outcomes

  1. Intra Ocular pressure (IOP)

    Time frame: Month 24

Secondary outcomes

  1. Intra Ocular pressure (IOP)

    Time frame: day 1,week 1, and months 1, 3, 6, 9, 12 and 18

  2. Changes in visual acuity

    Time frame: day 1,week 1, and months 1, 3, 6, 9, 12, 18, and 24.

  3. Number of anti-glaucoma medications

    Time frame: week 1, and months 1, 3, 6, 9, 12, 18, and 24

  4. Mean deviation of visual field,

    Time frame: week 1, and months 1, 3, 6, 9, 12, 18, and 24

  5. Rate of intra- and postoperative complications

    Time frame: week 1, and months 1, 3, 6, 9, 12, 18, and 24

07

Study locations

1 site
  • Vanak Eye Surgery Center
    Tehran, Iran, Islamic Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00971061
Lead sponsor
Vanak Eye Surgery Center
First posted
Sep 3, 2009
Start date
Jan 2003
Primary completion
Aug 2005
Completion
Aug 2005
Last update
Sep 4, 2009

Study contacts

Nader Nassiri, MD
principal investigator · Assistant Professor, Department of Ophthalmology, Imam Hussein Medical Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
Nariman Nassiri, MD
principal investigator · Medical Researcher, Vanak Eye Surgery Center, Tehran, Iran
Ghazal Kamali, MD
principal investigator · 4th-year Resident, Department of Ophthalmology, Imam Hussein Medical Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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